BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AERO JET VENTILATION CATHETER

    MDR report key: 24404015 · Received February 20, 2026

    Report

    Report Number
    3041679947-2026-00002
    Event Type
    Injury
    Date Received
    February 20, 2026
    Date of Event
    December 29, 2025
    Report Date
    January 22, 2026
    Manufacturer
    PIPELINE MEDICAL PRODUCTS, LLC
    Product Code
    BTR
    UDI-DI
    00860014685200
    PMA / PMN Number
    K243579
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EVALUATION WAS NOT PERFORMED AS THE PRODUCT WAS NOT PROVIDED FOR EVALUATION. A REVIEW OF THE DHR WAS PERFORMED- DEVICE WAS MANUFACTURED ACCORDING TO ALL REQUIREMENTS AND SPECIFICATIONS. A DEFINITIVE CAUSE FOR THIS REPORTED OBSERVATION COULD NOT BE DETERMINED. PRODUCT WORKED AS EXPECTED DURING PROCEDURE.

    Description of Event or Problem · 0

    A PATIENT PRESENTED WITH MILD NECK EMPHYSEMA IN THE PACU AFTER A SUSPENSION MICROSCOPIC LARYNGOSCOPY (SML) PROCEDURE. DURING THE SML PROCEDURE IN THE OR, INTUBATION WAS NOTED TO BE DIFFICULT. ONCE INTUBATED, CASE PROCEEDED NORMALLY AND WAS COMPLETED. EVERYTHING IN CASE WAS CONSIDERED NORMAL AND AS EXPECTED. JET VENTILATION WAS UTILIZED DURING THIS PROCEDURE. POST OPERATIVELY, MILD NECK EMPHYSEMA (SUB Q AIR) WAS NOTED IN THE PACU. A DIAGNOSTIC BRONCHOSCOPY WAS DONE TO ASSESS IF THERE WAS ANY DAMAGE TO THE TRACHEA DURING INTUBATION. NOT TRACHEAL DAMAGE OR TEARS WERE IDENTIFIED. PATIENT REMAINED IN HOSPITAL FOR A FEW DAYS UNTIL EMPHYSEMA RESOLVED AND WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466953 AERO JET VENTILATION CATHETER JET VENTILATION TUBE BTR PIPELINE MEDICAL PRODUCTS, LLC AERO-SA1 1210514A (FROM SALES DATA) 00860014685200

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization